- Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols, as well as Validation/Qualification Policies.
- Initiate Change Controls - provide validation assessments and remediation plans as required by the system/equipment/components.
- Develop Commissioning and Qualification Plans.
- Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211, as well as adherence to ICH Q7.
- Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
- Assure Compliance with FDA and EU Regulations.
- Evaluate, document, and develop investigations attributed to qualifications failures.
- Author Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- Assure all the qualification items are tracked and successfully completed.
- Perform GAP analysis and provide recommendations for existing qualifications.
- Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.)
- Bachelor's or Master's degree in Engineering, Science, or a related field.
- 3+ years of experience with commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies. Temperature mapping is a plus
- Pharmaceutical, healthcare, or medical device industry experience is a plus
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Validation Engineer
3 weeks ago
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Validation Engineer - Westchester, United States - Sterling Engineering
Description
Job Overview:
The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new standards for compliance purposes.
Responsibilities:
Preferred/Required Education/Skills:
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
